The HRPP FYI Process and the UPIRSO/SAE Review Sheet

1. The HRPP FYI Process and the UPIRSO/SAE Review Sheet An IRB Infoshort February 2014

2. FYIs • FYIs are notifications to the IRB regarding a specific research activity or event that does not invoke a standard protocol submission.

3. FYIs - 2 • A variety of items are submitted to the IRB as For Your Information (FYI), rather than as applications. These include: • UPIRSOs • Adverse Events (internal and external) • Subject complaints • Noncompliance—protocol deviations • Breach of confidentiality (e.g., lost/stolen laptop) • DSMB reports not associated with a re-approval application • Other Yale review committee approvals (Radiation Safety, etc.) • Certificates of Confidentiality

4. FYIs – 3 • QA monitoring Visits or Audit reports • FDA Notifications • External IRB/Foreign IRB/equivalent notices and approvals • Letters of support from Non-Government Organizations • Signed agreements from participating schools • Investigator brochures • Publications • Sponsor Close Out Visits

5. FYIs - 4 • Some submissions (if received by the IRB) do not require IRB acknowledgment, unless requested by the investigator: • Adverse events that do not meet our reporting requirements • Non data-collection tools from sponsors (e.g., blank calendars for subjects) • Public relations documents that do not require IRB review and approval • Investigator brochure edits that are made to correct pagination, manufacturer’s address, etc.

6. The FYI Process • The Regulatory Analyst reviews FYI notifications related to her committee and determines the level of review and response required. • The submission • May be returned to the researcher as unnecessary or incomplete • May require a regulatory review • May require review by the HRPP Compliance unit and/or Chair for additional action as deemed necessary.

7. The FYI Process - 2 • If the FYI submission requires further information from the researcher, the regulatory analyst will request this information from the study team. • For UPIRSOs and Adverse Events, the Regulatory Analyst will confirm whether the report meets the required criteria. This is documented on the UPIRSO & SAE Review Sheet.

8. UPIRSO/SAE Review Sheet (p.1)

9. UPIRSO/SAE Review Sheet (p. 2)

10. THE FYI Process - 3 • If the required elements are not met, review by the IRB Chair or other qualified designee will not proceed, and the Regulatory Analyst will notify the researcher, providing education on required submission criteria.

11. The FYI Process - 4 • If the confirmed report concerns an event that may be serious, unanticipated, and related to participation in the research study or an unanticipated problem that places, placed, or has the potential to place research subjects or others at risk of harm, then the report and any accompanying information is forwarded to the appropriate Chair, Vice-Chair or other qualified designee for review. The Chairperson or designee will determine if the report raises new concerns about risks and will recommend further review by the convened IRB, as necessary, for final determination.

12. The FYI Process – 5 • If the Chair, Vice-Chair or other qualified designee determine that a submission requires full IRB Committee review, scheduling will be set. If the protocol has been scheduled for another action (e.g., annual renewal) the submission will be reviewed with that action. If there is no current action pending, the submission will be reviewed by the Committee as a stand-alone item.

13. The FYI Process - 6 • The Committee will review the issue and will make a determination regarding whether is constitutes an unanticipated problem involving risks to subjects or others and iffurther action is necessary.